FDA.reportPublic FDA data

Methylphenidate Hydrochloride

Product NDC
13107-380
11-digit product format
131070380
Labeler code
13107
Product ID
13107-380_f821bfff-5013-4850-8e10-33e5c146df4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma, LLC
Application
ANDA209276
Marketing category
ANDA
Marketing start
2017-04-11
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylphenidate Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPHENIDATE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B3SC438HI
Rxcui1091150, 1091392, 1091497

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
143536be-f21a-464c-bc5a-163f5c171815Product name220250626
fd4d0878-dcea-3832-288e-e3bbbbe580ffProduct name920240516
435f0341-cf24-41d5-8fbf-c909821e5596Product name120230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436Product name220221216
67aa32c6-44f4-50de-64dd-643e8caf420dProduct name620210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440Product name420210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8Product name120200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1Product name120190828
343a61d5-785d-cc27-a43a-0779da054d88Product name320190828
7607489b-cd15-3103-f3b1-d4283574d250Product name220190614
407f0cce-da29-4050-a512-2cabe9e5692dProduct name920190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38eProduct name220190415
190572d9-6c7b-4b40-8172-c1b5f802c20fProduct name120180724
2948856e-f76e-d380-d9ed-b317efafbc98Product name520180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695Product name120170803
3317aade-2d6e-f159-9fe6-e8385a825178Product name320160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3Product name120160111

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13107-380-012024-08-07C16284748780-1f386c649-c5b9-0266-e053-dadaa90a7c1aMethlyphenidate Hydrochloride Tablets, USP CII These highlights do not include all the information needed to use Methlyphenidate Hydrochloride Tablet safely and effectively. See full prescribing information for Methlyphenidate Hydrochloride Tablet. Initial U.S. Approval: 1955
13107-380-012023-01-30C16284748780-1f386c649-c5b9-0266-e053-dadaa90a7c1aMethlyphenidate Hydrochloride Tablets, USP CII These highlights do not include all the information needed to use Methlyphenidate Hydrochloride Tablet safely and effectively. See full prescribing information for Methlyphenidate Hydrochloride Tablet. Initial U.S. Approval: 1955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-380-01Methylphenidate Hydrochloride100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-380METHYLPHENIDATE HYDROCHLORIDE TABLET [AUROLIFE PHARMA, LLC]3Current NDC, Legacy NDC, 1 package rows20240808_35be77db-fbe3-487e-a220-a08a11aaec28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091150methylphenidate HCl 10 MG Oral TabletPSN35be77db-fbe3-487e-a220-a08a11aaec284
1091392methylphenidate HCl 20 MG Oral TabletPSN35be77db-fbe3-487e-a220-a08a11aaec284
1091497methylphenidate HCl 5 MG Oral TabletPSN35be77db-fbe3-487e-a220-a08a11aaec284
1091150methylphenidate hydrochloride 10 MG Oral TabletSCD35be77db-fbe3-487e-a220-a08a11aaec284
1091392methylphenidate hydrochloride 20 MG Oral TabletSCD35be77db-fbe3-487e-a220-a08a11aaec284
1091497methylphenidate hydrochloride 5 MG Oral TabletSCD35be77db-fbe3-487e-a220-a08a11aaec284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-380-0113107038001100 TABLET in 1 BOTTLE (13107-380-01) 100 tablet2017-04-110000-00-00NoNoCurrent